From Telecommunications Authority
Regulation on Radio and Telecommunications Terminal Equipment
CHAPTER ONE
Objective, Scope, Legal Basis and Definitions
Objective
Article 1- The objective of this Regulation is to lay down the provisions and procedures
relating to the conformity assessment procedures, minimum criteria to meet the assignment of
the notified body, market surveillance and inspection in order to ensure that the radio and
telecommunications terminal equipment is placing on the market with the essential
requirements to be met.
Scope
Article 2- The Regulation covers; all related activities of the design of the radio and
telecommunications terminal equipment of the public bodies and authorities and real and legal
persons, the manufacturing, distribution, placing on the market, putting into service, usage
and the surveillance.
This Regulation shall apply for the following apparatus, excluding the apparatus exclusively
used for activities concerning public security, defense, State security and the activities of the
State in area of criminal law and the equipment listed in Annex I;
a) Radio equipment and telecommunications terminal equipment,
b) Provided that the provisions of Regulations in this item are reserved, an active
implantable medical device specified in sub-paragraph (e) of the Article 4 of the
Regulation on An Active Implantable Medical Device published in Official
Gazette No. 24693 dated 12 March 2002 and an integral part or an accessory of a
medical device specified in sub-paragraph (i) of the Article 4 of the Regulation on
Medical Device published in Official Gazette No: 24694 dated 13 March 2002,
c) Provided that the provisions of Regulations in this item are reserved, where
apparatus constitutes a component or a separate technical unit of a vehicle
specified in the sub-paragraph (d) of the Article 4 of the Type Approval
Regulation on Motor Vehicles Electromagnetic Compatibility (Radio Interference)
published in Official Gazette No: 24601 dated 5 January 2002 or a component or a
separate technical unit of a vehicle specified in the sub-paragraph (d) of the Article
4 of the Type Approval Regulation on Two or Three-Wheel Motor Vehicles
published in Official Gazette No: 23743 dated 2 July 1999.
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Legal Basis
Article 3- This Regulation has been prepared on the basis of Radiocommunication Law No:
2813, and Law on Telegram and Telephony No: 406 and Law relating to the Preparation and
Implementation of the Technical Legislation on the Products No: 4703.
Definitions
Article 4- For the purposes of this Regulation;
Undersecretariat shall mean the Undersecretariat for Foreign Trade,
Board: Telecommunication Board
Authority: Telecommunications Authority
Commission: European Commission
Radio equipment shall mean a product or relevant component that provides communication
by means of the emmision and/or reception of electromagnetic waves of frequencies from 9
kHz to 3 000 GHz, propagated in space without artificial guide,
Telecommunications terminal equipment shall mean a product or relevant component
connected directly or indirectly to the public telecommunication networks,
Apparatus shall mean the radio equipment and/or telecommunications terminal equipment,
Interface shall mean
(i) a network termination point, which is a physical connection point at which a user is
provided with access to public telecommunications network, and/or
(ii) an air interface specifying the radio path between radio equipment and their technical
specifications,
Harmful Interference shall mean interference which endangers the functioning of at
radionavigation service or other safety services or which otherwise seriously degrades,
obstructs or repeatedly interrupts a radiocommunications service operating in accordance with
the applicable national Regulation,.
Technical Construction File shall mean a file describing the apparatus and providing
information and explanations as to how the applicable essential requirements have been
implemented.
CHAPTER TWO
Essential Requirements, Publication of Interface Specifications,
Harmonized European Standards and Harmonized National Standard
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Essential Requirements
Article 5- The requirements relating to the essential requirements are specified as follows:
a) The apparatus shall comply with the provisions relating to the protection of the
health and the safety of the user and any other person, including the objectives with
respect to safety requirements contained in the Regulation on the Electrical Apparatus
Designed to be Used With A Particular Voltage published in Official Gazette No:
24637 dated 11 January 2002 by Ministry of Industry and Trade, but with no voltage
limit applying.
b) The apparatus shall comply with the provisions relating to the protection
requirements with respect to electromagnetic compatibility contained in the
Regulation on Electromagnetic Compatibility published in Official Gazette No: 24773
dated 2 June 2002 by Ministry of Industry and Trade.
c) The Radio equipment shall be so constructed that it effectively uses the spectrum
allocated to terrestrial/space radio communication and orbital resources so as to avoid
harmful interference.
d) Authority may decide that apparatus within certain equipment classes or apparatus
of particular types shall be so constracted that:
1) It shall work in harmony with the proper interface type when connected to the
public telecommunication network; and/or that
2) It does not harm the network or its functioning nor misuse network resources,
thereby causing an unacceptable degradation of service; and/or that
3) It incorporates safeguards to ensure that the personal data and privacy of the
user and of the subscriber are protected; and/or that
4) It supports certain features ensuring avoidance of fraud; and/or that
5) It supports certain features ensuring access to emergency services; and/or that
6) It supports certain features in order to facilitate its use by users with a disability.
Publication of Interface Specifications
Article 6- Operators of the public telecommunications networks shall be liable to publish
the network interface information and its technical specifications in accordance with the
provisions and procedures to be determined by the Authority.
Harmonised European Standard and Harmonised National Standard
Article 7- The provisions relating to the standards are specified as follows:
a) The apparatus that was manufactured in compliance with harmonised European
standard or harmonised National standard published on the basis of this standard,
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including at least one of the essential requirements specified in this Regulation hereby
shall be considered to comply with the relevant essential requirements.
b) The Authority publishes the list containing the harmonised European standards
and harmonised National standards in the Official Gazette.
c) Where the Authority considers that conformity with a harmonised standard does
not ensure compliance with essential requirement refered to in Article 5 which the said
standard is intended to cover, the Authority shall advise the Undersecretariat of the
need for investigation.
d) In the case of shortcoming of harmonised European standards or harmonised
National standards published on the basis of these standards with respect to the
essential requirements, the Authority shall exclude the respective national harmonised
standards or harmonised European standards from the list.
CHAPTER THREE
Placing On the Market, Putting into service and right to connect, The Apparatus to be
displayed
Placing on the market
Article 8- The manufacturer that manufactured the apparatus complies with the appropriate
essential requirements identified in Article 5 and the other relevant provisions of this
Regulation shall,
a) Provide demonstration and usage manual of the apparatus, the information related
to the usage purpose of the apparatus and the Declaration of Conformity together with
the apparatus in Turkish and in its original language, furthermore;
1) For radio equipment, present to the attention of the users the information related to
the country and geographical region the apparatus is used, limitation and/or
permission conditions on the package of the apparatus in the demonstration manual by
using the mark specified in Annex- VII.
2) Present to the attention of the users the information related to the interfaces for the
telecommunications terminal equipment on the package of the apparatus, or
introduction and usage manual or if possible on the apparatus itself.
b) Apply to the Authority for permission at least four weeks before placing the
apparatus that uses non-harmonised frequency or frequency bands to the market under
the procedures determined by the Authority.
Putting into service and right to connect
Article 9- The provisions and procedures relating to the put into service of appartus for its
intended purpose and right to connect are specified as follows:
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a) The apparatus may be put into service in line with its intended usage provided that
the apparatus complies with the essential requirements and other related provisions of
this Regulation.
b) Notwithstanding the sub-paragraph (a) of this article, in the event that the
apparatus affects the human health or causes interference, or inefficient and improper
use of the frequency spectrum, the Authority may restrict the putting into service such
apparatus .
c) Without prejudice to (d) of this article, the public telecommunications networks
operator shall not refuse to connect telecommunications terminal equipment to
appropriate interfaces on tecnical grounds where that equipment complies with the
applicable requirements of Article 5 and related provisions of this Regulation with the
proper interfaces.
d) In the event that the apparatus that is compliant with the provisions of this
Regulation causes serious damage to the network or its operation or cause
interference, the public telecommunications networks operator shall inform the
Authority of this issue.
e) In case of emergency, a public telecommunications networks operator may
disconnect the apparatus if the protection of the network requires the equipment to be
disconnected without delay and if the user can be offered, without delay and without
costs for him, an alternative solution. The operator shall immediately inform the
Authority.
The Apparatus to be displayed
Article 10- Provided that the apparatus has the marking specified in Article 6 of the AnnexVII, it may be displayed in fair, exhibition or similar occasions for demonstration purposes.
CHAPTER FOUR
Conformity Assessment Procedures
Conformity Assessment Procedures
Article 11- The provisions related to the conformity assessment procedures are as follows:
a) The conformity assessment procedures shall be used to demonstrate the
compliance of the apparatus with all the relevant essential requirements identified in
Article 5.
b) At the choice of the manufacturer, compliance of the apparatus with the essential
requirements identified in sub-paragraphs (a) and (b) of the Article 5 of this
Regulation may be demonstrated using the procedures specified in the Regulation on
the Electrical Apparatus Designed to be Used With A Particular Voltage published in
Official Gazette No: 24637 dated 11 January 2002 and the Regulation on
Electromagnetic Compatibility drafted by Ministry of
Industry and Trade
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respectively, where apparatus is within the scope of those Regulations, as an
alternative to the procedures defined in the sub-paragraphs (c), (d) and (e) of this
article.
Telecommunications terminal equipment which does not make use of the spectrum
allocated to terrestrial/space radio communication and receiving parts of radio
equipment shall be subject to the procedures described in any one of Annexes II, IV or
V at the choice of the manufacturer.
c)
d) Where a manufacturer has applied the harmonised European standard or
harmonised National standard published on the basis of this standards referred to in
Article 7(a), radio equipment not within the sub-paragraph (c) of this article shall be
subject to the procedures described in any one of Annexes III, IV or V at the choice of
the manufacturer.
e) Where a manufacturer has not applied or has only applied in part the the
harmonised European standard or harmonised National standard published on the
basis of this standards referred to in Article 7(a), radio equipment not within the subparagraph (c) of this article shall be subject to the procedures described in either of
Annexes IV or V at the choice of the manufacturer.
The documents related to the conformity assessment procedure shall be in Turkish or English.
The manufacturer shall publish the Declaration of Conformity of the apparatus in its original
language and in Turkish.
CHAPTER FIVE
Provisions for Notified Bodies
Provisions Related to the Notified Bodies
Article 12- The provisions related to the Notified Bodies are specified as follows:
a) The bodies to be appointed by the Authority to serve as a Notified Body within the
scope of this Regulation shall have the minimum criteria specified in the Regulation
on Conformity Assessment Bodies and Notified Bodies published by the
Undersecretariat in Official Gazette No: 24643 dated 17 January 2002 and the Annex
VI.
b) The Board shall appoint testing, inspection and/or certification bodies established
in Turkey in a number to be determined by the Board, in order to perform the
conformity assessment procedures within the scope of this Regulation.
c) The Authority shall submit the information related to the name of testing, inspection
and/or certification bodies, the modules to be evaluated in terms of conformity and the
criteria to be considered in the selection of the apparatus to the Undersecretariat to
enable it submit the information to the Commission. Upon publication of the identity
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register number to be given by the Commission on the Official Gazette by the
Authority, the bodies shall gain notified body status.
d) In the event that the Authority finds that the body does not have the criteria
specified in the Annex- VI, the sub-paragraphs 2 and 3 of the Article 9 of the Law and
the Article 6 of the Regulation on Conformity Assessment Bodies and Notified Bodies
published by the Undersecretariat on Official Gazette No: 24643 dated 17 January
2002 are implemented. The decisions relating to the suspension of the activities of the
Notified bodies or abrogation of the notified body status taken by the Authority shall
be published in Official Gazette and informed to the Undersecretariat to enable it
submit to the Commission.
e) The notified bodies are liable to maintain the information, registry and the
documents for 10 years.
CHAPTER SIX
Market Surveillance, Prohibition of the Placing on the Market of Apparatus,
Withdrawal and Destruction of the Apparatus on the Market
Market surveillance
Article 13- The Authority shall supervise or ensure supervision of whether the apparatus was
manufactured and marketed, whether it is put into the market in accordance with the
provisions of this Regulation, in the placing on the market or when the apparatus is available
in the market. The Authority may collect samples of the apparatus from the market or assign
other bodies for this activity and shall perform the surveillance activities in accordance with
the provisions specified in this Regulation. In the event that violation of the Regulation
provisions is detected, the provisions of Article 20 of this Regulation shall apply.
Prohibition of the placing on the market of apparatus, Withdrawal and destruction of
the apparatus on the market
Article 14- The provisions relating to the prohibition of the plancing on the market of
apparatus, withdrawal and destruction of the apparatus placed on the market are specified as
follows:
a) In the event that it is detected the apparatus in the scope of this Regulation is not
compliant with the provisions of this Regulation, the Authority shall take the
necessary measures to prevent marketing or putting into service of the apparatus, to
remove the apparatus from the market or the service or to limit the free circulation of
the apparatus.
b) In the event that it is detected the apparatus is not safe, even if the conformity with
this Regulation is certified, the Authority shall take the decision of ceasing the
placement of the apparatus in the market temporarily until the apparatus is checked,
and informs the manufacturer of such decision.
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c) Even if it is certified that the apparatus is tested comply with this Regulation, if it
is detected that the apparatus is not safe after the inspections within the scope of the
market surveillance, the Authority shall take the necessary measures, expenses being
covered by the manufacturer.
d) For the radio equipment that cause the interference in the current services or
supposed to cause if used, the Authority shall take the necessary measures to:
1) Prohibition or restriction the placing on the market of the apparatus and/or
2) Withdrawal of the apparatus placed on the market and if it possible, the
manufacturer to recover the unsafely of a apparatus and
3) Whole or partial disposal of the apparatus in case it is impossible to recover the
unsafely or unsafely is not recovered by the manufacturer.
CHAPTER SEVEN
Marking
Marking
Article 15- The provisions attaching and using the “CE” conformity marking are specified
as follows:
a) If the apparatus meets the essential requirements of this Regulation and other
related provisions prior to placement on the market, the “CE” marking specified in
Annex VII shall be affixed on the apparatus, its package, introduction and manuals.
b) In the event that the procedures identified in Annex III, Annex IV or Annex V are
applied, the identification number of the notified body given by the Commission shall
be placed next to the “CE” marking. The Notified Body shall ensure that the apparatus
has identity registry number be affixed on the apparatus, on its package, on the
demonstration and usage manuals.
c) If the apparatus is radio equipment, besides the markings specified in the subparagraph (b) of this article, the class identification the apparatus specified in the
Annex VII shall be put on the apparatus.
d) Provided that they do not hinder the visibility and eligibility of the “CE” marking,
another markings and signals that show pictogram and usage features of the apparatus
may be attached following the “CE” conformity marking and the identity registry
number of the certifying notified body.
e) The other markings and signals that may mislead the third parties about the shape
and meaning of the “CE” marking shall not be attached on the apparatus, on the
package, in the demonstration and usage manuals.
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f) In the event that attaching “CE” marking is subjected to more than one technical
Regulation, the “CE” marking shall ensure that the apparatus has the essential
requirements of the respective technical Regulations. If one or more of the said
technical Regulations provide the user more than one choice during a transition
period, the “CE” marking shall only ensure the conformity with the applied technical
Regulations. In this respect, the applied provisions of the respective technical
Regulation shall be attached to the document of the product accompanying the
product, on the package, in the demonstration and usage manuals and on the apparatus
if possible.
g) In the event that it was detected that “CE” marking was affixed to the apparatus
though it did not have the essential requirements specified in the sub-paragraphs (a),
(b) and (c) of this article, the Authority shall take the necessary measures, related
expenses being covered by the manufacturer.
CHAPTER EIGHT
Miscellaneous provisions
Harmonized European Union Legislation
Article 16- This Regulation was prepared in accordance with the Directive No. 1999/5/EC of
the European Parliament dated March 9,1999 that replaced abolished Directives No
91/263/EEC and 98/13/EEC in terms of the radio and telecommunication equipment and the
mutual recognition of the conformity of these equipment, the conditions and requirements
specified in Annex 1 of the Partnership Council Decision NO. 2/97 between Turkey and
European Union.
Notification
Article 17- The Undersecretariat shall inform the Commission and member countries of
European Union of putting into effect this Regulation that was drafted by the Authority in
accordance with the Directive No: 1999/5/EC.
Confidentiality
Article 18- The Authority, the Notified Body and other parties involved in the
implementation of this Regulation shall ensure the confidentiality of the information they
have as regards the issue. The confidential information shall only be disclosed for the
requirements of public health and security upon the demand of the legal authorities and by
informing the Authority of the issue.
Unspecified Conditions
Article 19- In the event that there are unspecified conditions in the Regulation, the
Undersecretariat shall implement the Regulation on Conformity Assessment Bodies and
Notified Bodies published in Official Gazette No: 24643 dated 17 January 2002, Regulation
on Market Surveillance of the Products and Regulation on Attaching and Using the “CE”
Marking on the Products.
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Penal Provisions
Article 20- For those that acted and performed activities in contrast with the provisions of this
Regulation, the Law on Preparation and Application of Technical Legislation of Products No.
4703 and other provisions of the legislation shall be implemented.
Guidelines
Article 21- The Authority shall prepare the guidelines regarding application of this
Regulation.
The Provisions not to be applied
Article 22- As of the date on which this Regulation takes effect, for the apparatus under scope
of the Regulation, this Regulation and following provisions out of the scope of the Regulation
shall not be applied.
a) Sub-paragraphs (a), (b) and (c) of the Article 5, the sub-paragraphs (a), (b), (c) and
(d) of the Article 7, the Article 8, Annex I and Annex III of the Regulation on
Electromagnetic Compatibility No 89/336/AT.
b) Sub-paragraph 1 of Article 5, Annex I, Section B of Annex III and Annex IV of
the Regulation on the Electrical Apparatuses Designed to be Used with a Particular
Voltage No 73/3/AT published in Official Gazette No: 24637 dated 11 January 2002.
Provisional Item 1- The apparatus producers still active in the market, which fall under this
regulation, are liable to take the necessary measures until the enforcement date of this
Regulation.
Provisional Item 2- The apparatus to be marketed under the scope of this Regulation shall
ensure conformity with the provisions of this Regulation within a year after as of the effective
date of this Regulation.
Enforcement
Article 23- This Regulation shall be put into the force when it is published in the Official
Gazette.
Execution
Article 24- The Director of Board shall perform the application of the provisions of this
Regulation
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ANNEX I
APPARATUS EXCLUDED BY THE REGULATION
The other equipment excluded by this Regulation is as follows:
1. Amateur radio equipment or circuit cards involved in amateur radio spectrum and nonavailable on the market,
2. Maritime navigational apparatus to be used as mandatory equipment in sea vehicles within
the scope of SOLAS and IMO,
3. The cables and wires,
4. The receivers used only for receiving the Radio and TV broadcasts,
5. VOR, DME, VORTAC, ILS, NDB and air radio navigational apparatuses used in Civil
Aviation Services,
6. The monitoring and direction finding systems used in air traffic management and VOR,
DME, VORTAC, ILS, NDB and RADAR equipment used in communication systems.
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ANNEX II
CONFORMITY ASSESSMENT PROCEDURE REFERRED IN ARTICLE 11 (C)
Module A (Internal Production Control)
1. This module describes the procedure whereby the manufacturer or his authorised
representative, who carries out the obligations laid down in point 2, ensures and declares that
the products concerned satisfy the requirements of this Directive that apply to them. The
manufacturer or his authorised representative must affix the CE marking to each product and
draw up a written declaration of conformity.
2. The manufacturer must establish the technical documentation described in point 4 and he or
his authorised representative must keep it for a period ending at least 10 years after the last
product has been manufactured at the disposal of the relevant national authorities of any
Member State for inspection purposes.
3. Where neither the manufacturer nor his authorised representative is established within
Turkey, the obligation to keep the technical documentation available is the responsibility of
the person who places the product on the market.
4. The technical documentation must enable the conformity of the product with the essential
requirements to be assessed. It must cover the design, manufacture and operation of the
product, in particular:






a general description of the product,
conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of said drawings and
schemes and the operation of the product,
a list of the standards referred to in Article 5, applied in full or in part, and
descriptions and explanations of the solutions adopted to meet the essential
requirements of the Directive where such standards referred to in Article 5 have not
been applied or do not exist,
results of design calculations made, examinations carried out, etc.,
test reports.
5. The manufacturer or his authorised representative must keep a copy of the declaration of
conformity with the technical documentation.
6. The manufacturer must take all measures necessary in order that the manufacturing process
ensures compliance of the manufactured products with the technical documentation referred
to in point 2 and with the requirements
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ANNEX III
CONFORMITY ASSESSMENT PROCEDURE SPECIFIED IN ARTICLE 11 (d)
(Internal production control plusspecific apparatus tests)
This Annex consists of Annex II, plus the following supplementary requirements:
For each type of apparatus, all essential radio test suites must be carried out by the
manufacturer or on his behalf. The identification of the test suites that are considered to be
essential is the responsibility of a notified body chosen by the manufacturer except where the
test suites are defined in the harmonised standards. The notified body must take due account
of previous decisions made by notified bodies acting together.
The manufacturer or his authorised representative or the person responsible for placing the
apparatus on the market must declare that these tests have been carried out and that the
apparatus complies with the essential requirements and must affix the notified body's
identification number during the manufacturing process.
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ANNEX IV
CONFORMITY ASSESSMENT PROCEDURE SPECIFIED IN ARTICLE 11 (e)
(Technical construction file)
This Annex consists of Annex III plus the following supplementary requirements:
The technical documentation described in point 4 of Annex II and the declaration of
conformity to specific radio test suites described in Annex III must form a technical
construction file.
The manufacturer, his authorised representative or the person responsible for placing the
apparatus on the market, must present the file to one or more notified bodies, each of the
notified bodies must be informed of others who have received the file.
The notified body must review the file and if it is considered that it has not been properly
demonstrated that the requirements of the Directive have been met, the notified body may
issue an opinion to the manufacturer, his representative or the person responsible for placing
the apparatus on the market and must inform the other notified bodies who have received the
file accordingly. Such an opinion must be given within four weeks of receipt of the file by the
notified body. On receipt of this opinion, or after the end of the four-week period, the
apparatus may be placed on the market, without prejudice to Articles 6(4) and 9(5).
The manufacturer or his authorised representative or the person responsible for placing the
apparatus on the market must keep the file for a period ending at least 10 years after the last
apparatus has been manufactured at the disposal of the relevant national authorities of any
Member States for inspection.
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ANNEX V
CONFORMITY ASSESSMENT PROCEDURE SPECIFIED IN ARTICLE 11
(Full quality assurance)
Full quality assurance is the procedure whereby the manufacturer who satisfies the
obligations of point 2 ensures and declares that the products concerned satisfy the
requirements of the Directive that apply to them. The manufacturer must affix the marks
referred to in Article 12(1) to each product and draw up a written declaration of conformity.
1.
2. The manufacturer must operate an approved quality system for design, manufacture and
final product inspection and testing as specified in point 3 and must be subject to surveillance
as specified in point 4.
3. Quality system
3.1 The manufacturer must lodge an application for assessment of his quality system with a
notified body. The application must include:


all relevant information for the products envisaged,
the quality system's documentation.
3.2. The quality system must ensure compliance of the products with the requirements of the
Directive that apply to them. All the elements, requirements and provisions adopted by the
manufacturer must be documented in a systematic and orderly manner in the form of written
policies, procedures and instructions. This quality system documentation must ensure a
common understanding of the quality policies and procedures such as quality programmes,
plans, manuals and records.
It must contain in particular an adequate description of:





the quality objectives and the organizational structure, responsibilities and powers of
the management with regard to design and product quality,
the technical specifications, including the harmonized standards and technical
regulations as well as relevant test specifications that will be applied and, where the
standards referred to in Article 5(1) will not be applied in full, the means that will be
used to ensure that the essential requirements of the Directive that apply to the
products will be met,
the design control and design verification techniques, processes and systematic actions
that will be used when designing the products pertaining to the product category
covered,
the corresponding manufacturing, quality control and quality assurance techniques,
processes and systematic actions that will be used,
the examinations and tests that will be carried out before, during and after
manufacture, and the frequency with which they will be carried out, as well as the
results of the tests carried out before manufacture where appropriate,
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


the means by which it is ensured that the test and examination facilities respect the
appropriate requirements for the performance of the necessary test,
the quality records, such as inspection reports and test data, calibration data,
qualification reports of the personnel concerned, etc.,
the means to monitor the achievement of the required design and product quality and
the effective operation of the quality system.
3.3. The notified body must assess the quality system to determine whether it satisfies the
requirements referred to in point 3.2. It must presume compliance with these requirements in
respect of quality systems that implement the relevant harmonized standard.
The notified body must assess in particular whether the quality control system ensures
conformity of the products with the requirements of the Directive in the light of the relevant
documentation supplied in respect of points 3.1 and 3.2 including, where relevant, test results
supplied by the manufacturer.
The auditing team must have at least one member experienced as an assessor in the product
technology concerned. The evaluation procedure must include an assessment visit to the
manufacturer's premises.
The decision must be notified to the manufacturer. The notification must contain the
conclusions of the examination and the reasoned assessment decision.
3.4. The manufacturer must undertake to fulfill the obligations arising out of the quality
system as approved and to uphold it so that it remains adequate and efficient.
The manufacturer or his authorised representative must keep the notified body that has
approved the quality system informed of any intended updating of the quality system.
The notified body must evaluate the modifications proposed and decide whether the amended
quality system will still satisfy the requirements referred to in point 3.2 or whether a
reassessment is required.
It must notify its decision to the manufacturer. The notification must contain the conclusions
of the examination and the reasoned assessment decision.
4. EC surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection purposes to the
locations of design, manufacture, inspection and testing, and storage and must provide it with
all necessary information, in particular:

the quality system documentation,
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

the quality records as foreseen by the design part of the quality system, such as results
of analyses, calculations, tests, etc.,
the quality records as foreseen by the manufacturing part of the quality system, such
as inspection reports and test data, calibration data, qualification reports of the
personnel concerned, etc.
4.3. The notified body must carry out audits at reasonable intervals to make sure that the
manufacturer maintains and applies the quality system and must provide an audit report to the
manufacturer.
4.4. Additionally, the notified body may pay unexpected visits to the manufacturer. At the
time of such visits, the notified body may carry out tests or have them carried out in order to
check the proper functioning of the quality system where necessary; it must provide the
manufacturer with a visit report and, if a test has been carried out, with a test report.
5. The manufacturer must, for a period ending at least 10 years after the last product has been
manufactured, keep at the disposal of the national authorities:



the documentation referred to in the second indent of point 3.1,
the updating referred to in the second paragraph of point 3.4,
the decisions and reports from the notified body which are referred to in the final
paragraph of point 3.4 and in points 4.3 and 4.4.
6. Each notified body must make available to the other notified bodies the relevant
information concerning quality system approvals including references to the product(s)
concerned, issued and withdrawn.
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ANNEX VI
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY AUTHORITY WHEN
DESIGNATING NOTIFIED BODIES
1.
The notified body, its director and the staff responsible for carrying out the tasks for which
the notified body has been designated must not be a designer, manufacturer, supplier or
installer of radio equipment or telecommunications terminal equipment, or a network operator
or a service provider, nor the authorised representative of any of such parties. They must be
independent and not become directly involved in the design, construction, marketing or
maintenance of radio equipment or telecommunications terminal equipment, nor represent the
parties engaged in these activities. This does not preclude the possibility of exchanges of
technical information between the manufacturer and the notified body.
2. The notified body and its staff must carry out the tasks for which the notified body has been
designated with the highest degree of professional integrity and technical competence and
must be free from all pressures and inducements, particularly financial, which might influence
their judgement or the results of any inspection, especially from persons or groups of persons
with an interest in such results.
3. The notified body must have at its disposal the necessary staff and facilities to enable it to
perform properly the administrative and technical work associated with the tasks for which it
has been designated.
4. The staff responsible for inspections must have:
i.sound technical and professional training,
ii.satisfactory knowledge of the requirements of the tests or inspections that are carried out
and adequate experience of such tests or inspections,
iii.the ability to draw up the certificates, records and reports required to authenticate the
performance of the inspections.
5. The impartiality of inspection staff must be guaranteed. Their remuneration must not
depend on the number of tests or inspections carried out nor on the results of such inspections.
6. The notified body must take out liability insurance unless its liability is assumed by the
Member State in accordance with national law, or the Member State itself is directly
responsible.
7. The staff of the notified body is bound to observe professional secrecy with regard to all
information gained in carrying out its tasks (except vis-...-vis the competent administrative
authorities of the Member State in which its activities are carried out) under this Directive or
any provision of national law giving effect thereto.
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ANNEX VII
LABELS AND MARKINGS TO BE USED ON APPARATUS
WITHIN THE SCOPE OF THIS REGULATION
1. "CE" marking shall be a height of at least 5 mm according to the format indicated below,
and the following ratios of draft drawing shall be taken into account in sizing.
2. "CE" marking shall be placed on the apparatus or identification plate. In addition, it shall be
affixed to the package and documents accompanying the apparatus, if any.
3. "CE" marking shall be at a legible size and affixed to the apparatus without any room for
erasing.
4. Apparatus evaluated to be similar shall be categorized as the following according to their
properties within the scope of this Regulation;
a) Class 1: Apparatus existing in the market and open to operation without any
restriction,
b) Class 2: Radio equipment, for which restrictions are established by the Authority
for servicing and existence in the market.
5. "Alert Sign" and "CE" marking shall be affixed to the apparatus within the scope of Class
2 at the same height.
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6. A label, which is sized according to the ratios specified in draft drawing below, shall be
affixed to the apparatus that is not in compliance with the provisions of the Regulation in a
visible and inerasable manner before exhibiting in fairs, exhibitions and similar places.
0
10
20
30
40
50
60
70
80
50
50
TANITIM
AMAÇLIDIR
SATILAMAZ
40
30
20
10
40
30
20
10
0
0
0
10
20
30
40
50
60
70
80
(For introduction considerations only, not for sale)
20